Enjaymo (sutimlimab-jome)

Covered: Enjaymo (sutimlimab‑jome) is covered for treatment of hemolysis in adults with cold agglutinin disease when strict clinical and laboratory criteria are met. Key requirements/exclusions: patient ≥18 years and ≥39 kg, symptomatic with documented chronic hemolysis, direct antiglobulin test strongly positive for C3d and negative/weak IgG, cold agglutinin titer ≥64 at 4°C, baseline hemoglobin ≤10 g/dL and total bilirubin above the lab ULN, secondary causes excluded, prescribed by/with a hematologist; approval up to 12 months with specified weight‑based IV dosing (6,500 mg for 39–75 kg or 7,500 mg for >75 kg: weekly ×2 then every 2 weeks); not covered if criteria are not met.

"Treatment of hemolysis in adults with cold agglutinin disease (FDA-approved indication)."

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